United States: U.S. EPA Takes Action Under TSCA Identifying Chemicals For Agency Scrutiny

Prioritization of Chemicals

In its continuing quest to meet regulatory deadlines imposed by
the 2016 amendments to the Toxic Substances Control Act (TSCA), the
United States Environmental Protection Agency (U.S. EPA) has published a list of 40 chemicals that must be
"prioritized" by the end of 2019. The announcement marks
the beginning of the Agency's process for designating the 40
listed chemicals identified as either "high" or
"low" priority substances for further the U.S. EPA
scrutiny. At the conclusion of the prioritization process, at least
20 of the substances likely will be designated as high
priority.

A high priority designation immediately commences the U.S.
EPA's formal "risk evaluation" procedures under the
amended statute. The risk evaluation process can lead to
"pause preemption" under the terms of the 2016 amendments
and new state laws and regulations restricting the manufacture,
processing, distribution, and use of a chemical substance
undergoing a risk evaluation could not be established until the
evaluation process is completed. The U.S. EPA commenced its first
10 risk evaluations as required under the amended law at the close
of 2016. The Agency is required to have an additional 20 risk
evaluations of high priority substances ongoing by December 22,
2019. If the U.S. EPA's risk evaluation process concludes that
a substance presents an "unreasonable risk" to health or
the environment under its "conditions of use," the Agency
must commence a rulemaking to prohibit or limit the use of the
substance under Section 6 of TSCA.

The Agency's announcement of the list of chemicals to
undergo prioritization provides the makers and users of the listed
substances an important, time limited opportunity to submit
relevant information such as the uses, hazards, and exposure for
these chemicals. The U.S. EPA has opened a docket for each of the
40 chemicals and the opportunity to submit information for the U.S.
EPA's consideration will close in 90 days (on June 19, 2019).
The U.S. EPA will then move to propose the designation of these
chemical substances as either high priority or low priority. The
statute requires the U.S. EPA to complete the prioritization
process, by finalizing its high priority and low priority
designations, within the next nine to 12 months.

The list of 20 substances to be reviewed as high priority
candidates consists entirely of substances previously identified by
U.S. EPA in 2014 as "Work Plan" chemicals. Thus, the list
contains few chemicals that should be considered complete
"surprises." However, the inclusion of formaldehyde may
raise concerns in certain quarters given the scrutiny that has been
given to the U.S. EPA's previous struggles with assessing the
potential effects of formaldehyde. The Agency has attempted to
address these concerns by stating "Moving forward evaluating
formaldehyde under the TSCA program does not mean that the
formaldehyde work done under IRIS will be lost. In fact, the work
done for IRIS will inform the TSCA process. By using our TSCA
authority EPA will be able to take regulatory steps; IRIS does not
have this authority." Also included in the listing are several
chlorinated solvents, phthalates, flame retardants, a fragrance
additive, and a polymer pre-curser:

The U.S. EPA has signaled that it has received a manufacturer
request for a EPA to undertake a risk evaluation of two additional
phthalates which, if administrative requirements for such request
have been met, the Agency would announce publicly in the very near
term.

The 20 low priority candidate chemicals were selected from the
U.S. EPA's "Safer Chemicals Ingredients List"—a
list of substances previously evaluated and considered to meet the
U.S. EPA's "Safer Choice" criteria for use in certain
common product categories, such as cleaning products.

Other Recent and Impending U.S. EPA Actions Under TSCA

Given the numerous deadlines that are looming under the
amendments to TSCA, it is critical that chemical manufacturers and
processors of chemicals and formulations remain aware of the recent
and upcoming actions under TSCA that can significantly impact their
businesses. The following provides a short list of important
actions of which to be aware.

Active/Inactive TSCA Inventory Designations. EPA
released an updated version of the TSCA Inventory in February 2019.
The Inventory is available for download here. This version of the Inventory includes
chemical substances reported by manufacturers and processors by
their respective reporting deadlines in 2018. The updated TSCA
Inventory (confidential and non-confidential versions) includes
40,655 "active" chemical substances and 45,573
"inactive" chemical substances. Once the current 90-day
"transition period" has concluded, it will be unlawful to
manufacture, import or process in the US any substance that is
listed as "inactive" without first providing notice to
the U.S. EPA. Thus, prior to the expiration of the "transition
period" on May 20, 2019, manufacturers and processors of
chemical substances that are not listed as active on the February
2019 TSCA Inventory must take steps to activate the substance by
filing a Notice of Activity (NOA Form B) for any chemical substance
that they currently are manufacturing or processing, or anticipate
manufacturing or processing within 90 days of submission.

Final TSCA Section 6(a) for Methylene Chloride in Paint and
Coating Removers. EPA has released its long-awaited TSCA Section 6(a) rule restricting the use of
methylene chloride in paint and coating removers. The final rule
prohibits the manufacture, processing, and distribution of
methylene chloride in paint removers for consumer use. The rule
prohibits the sale of methylene chloride-containing paint and
coating removers at retail establishments with any consumer sales
(including e-commerce sales). The U.S. EPA declined to finalize its
determination that the commercial use of methylene
chloride-containing paint and coating removers presents an
unreasonable risk. Therefore, distributors to commercial users,
industrial users, and other businesses will continue to be
permitted to distribute methylene chloride-containing paint and
coating removers. However, given recent efforts by store-front
retailers to "deselect" such products for consumer sales,
it remains unclear how distributions to commercial users can or
will occur.

The U.S. EPA simultaneously released an advanced notice of
proposed rulemaking related to a potential certification program
for commercial uses of methylene chloride-containing paint and
coating removers. The U.S. EPA has similar programs in place for
certain pesticides and refrigerants, and the United Kingdom
currently has in place a program to certify commercial users of
methylene chloride-containing paint and coating removers. The U.S.
EPA is seeking comment on whether a certification program is the
appropriate tool to address any potential risks that could be posed
by the commercial use of methylene chloride-containing paint and
coating removers.

Upcoming Draft Risk Evaluations. The U.S. EPA is
expected to publish within days or weeks the highly anticipated
draft Risk Evaluations for the remaining 9 of the 10 initial
substances to undergo TSCA Risk Evaluations under the amended law
and which have been under review since December 2016. The Agency
will accept comments on the drafts for a limited period.

Proposed Rules for 5 PBT substances. The U.S. EPA is
required to issue no later than June 2019 proposed TSCA Section 6
regulations for 5 persistent, bioaccumulative and toxic (PBT)
substances that were identified during 2016 as priorities for
regulatory action. The Agency must propose expedited rules intended
to reduce exposures to the extent practicable.

* Camille Heyboer also contributed to this
Advisory.

Originally published by Hazmat Management Magazine.

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